Trial Outcomes & Findings for CHALO! 2.0: A Mobile Technology Based Intervention to Accelerate HIV Testing and Linkage to Preventive Treatment. (NCT NCT04814654)

Results Overview

Verified HIV testing was assessed as a dichotomous measure (yes/no) of receipt of a documented HIV test. The number/percentage of participants who were verified to have been HIV tested within 6 months of randomization is summarized by study arm/group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1004 participants

Primary outcome timeframe

Within 6 months from randomization

Results posted on

2025-11-06

Participant Flow

For this study a total of 1191 were consented. Upon quality checking 187 participants were excluded after enrollment. After these exclusions 1004 participants were considered enrolled and were randomized.

Participant milestones

Participant milestones
Measure	CHALO! 2.0 MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers. CHALO! 2.0: The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) on the following topics: HIV testing, prevention, treatment, linkage-to-care; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Attention-matched Control (AMC) MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers. Attention-matched control (AMC): The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) only related to general health information; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Digital Coupon Only Control (DCO) MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services. Digital coupon only (DCO): The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.
Overall Study STARTED	339	332	333
Overall Study COMPLETED	169	165	176
Overall Study NOT COMPLETED	170	167	157

Reasons for withdrawal

Reasons for withdrawal
Measure	CHALO! 2.0 MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers. CHALO! 2.0: The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) on the following topics: HIV testing, prevention, treatment, linkage-to-care; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Attention-matched Control (AMC) MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers. Attention-matched control (AMC): The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) only related to general health information; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Digital Coupon Only Control (DCO) MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services. Digital coupon only (DCO): The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.
Overall Study due to administrative issues, implementation partner was unable to continue study activities.	170	167	157

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHALO! 2.0 n=339 Participants MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers. CHALO! 2.0: The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) on the following topics: HIV testing, prevention, treatment, linkage-to-care; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Attention-matched Control (AMC) n=332 Participants MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers. Attention-matched control (AMC): The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) only related to general health information; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Digital Coupon Only Control (DCO) n=333 Participants MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services. Digital coupon only (DCO): The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.	Total n=1004 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=339 Participants	0 Participants n=332 Participants	0 Participants n=333 Participants	0 Participants n=1004 Participants
Age, Categorical Between 18 and 65 years	339 Participants n=339 Participants	332 Participants n=332 Participants	333 Participants n=333 Participants	1004 Participants n=1004 Participants
Age, Categorical >=65 years	0 Participants n=339 Participants	0 Participants n=332 Participants	0 Participants n=333 Participants	0 Participants n=1004 Participants
Age, Continuous	28 Years STANDARD_DEVIATION 7 • n=339 Participants	28 Years STANDARD_DEVIATION 7 • n=332 Participants	28 Years STANDARD_DEVIATION 7 • n=333 Participants	28 Years STANDARD_DEVIATION 7 • n=1004 Participants
Sex: Female, Male Female	0 Participants n=339 Participants	0 Participants n=332 Participants	0 Participants n=333 Participants	0 Participants n=1004 Participants
Sex: Female, Male Male	339 Participants n=339 Participants	332 Participants n=332 Participants	333 Participants n=333 Participants	1004 Participants n=1004 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment India	339 participants n=339 Participants	332 participants n=332 Participants	333 participants n=333 Participants	1004 participants n=1004 Participants

PRIMARY outcome

Timeframe: Within 6 months from randomization

Verified HIV testing was assessed as a dichotomous measure (yes/no) of receipt of a documented HIV test. The number/percentage of participants who were verified to have been HIV tested within 6 months of randomization is summarized by study arm/group.

Outcome measures

Outcome measures
Measure	CHALO! 2.0 n=339 Participants MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers. CHALO! 2.0: The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) on the following topics: HIV testing, prevention, treatment, linkage-to-care; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Attention-matched Control (AMC) n=332 Participants MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers. Attention-matched control (AMC): The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) only related to general health information; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Digital Coupon Only Control (DCO) n=333 Participants MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services. Digital coupon only (DCO): The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.
Verified HIV Testing	30 Participants	30 Participants	29 Participants

PRIMARY outcome

Timeframe: Within 12 months from randomization

Linkage to prevention was assessed as a dichotomous (yes/no) measure and defined as a composite of either receipt of counseling or PrEP use within 12 months of randomization. The number/percentage of participants who meet the linkage to care composite criteria is summarized by study arm/group.

Outcome measures

Outcome measures
Measure	CHALO! 2.0 n=339 Participants MSM randomized to this arm will receive twice weekly digital media messages for 12 weeks about HIV, HIV-testing, prevention, and treatment and a a link to a study-specific webpage listing MSM specific testing, prevention, and care resources. Participants will also be able to interact with online outreach workers. CHALO! 2.0: The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) on the following topics: HIV testing, prevention, treatment, linkage-to-care; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Attention-matched Control (AMC) n=332 Participants MSM randomized to the AMC arm will receive twice weekly digital media messages for 12 weeks about general health and a link to a study-specific webpage listing testing resources and MSM-specific services. Participants will also be able to interact with online outreach workers. Attention-matched control (AMC): The components of the intervention are: Contents of digital-media (sent twice/week for 12 weeks) only related to general health information; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers.	Digital Coupon Only Control (DCO) n=333 Participants MSM randomized to the DCO arm will receive, at study entry, a digital coupon for free HIV testing and a study specific webpage link listing testing and MSM specific services. Digital coupon only (DCO): The components of the intervention are: Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers.
Linkage to Prevention	31 Participants	47 Participants	32 Participants

SECONDARY outcome

Timeframe: Within 18 months from randomization

Among participants who were tested, frequency of HIV testing is defined as the average (mean) number of verified HIV tests per participant within 18 months from randomization. Frequency of HIV testing is a measure of public health intervention effectiveness. Results are summarized by study arm/group using descriptive statistics.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 18 months from randomization

Receipt of a verified HIV test within 18 months of randomization was assessed as a dichotomous (yes/no) measure. The number/percentage of participants who were verified to have received HIV testing at each timepoint is summarized by study arm/group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 6 months from randomization

Self-reported HIV test within 6 months of randomization was assessed as a dichotomous (yes/no) measure. The number/percentage of participants who self-reported as having been HIV tested, but were unverified, within 6 months from randomization is summarized by study arm/group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 12 months from randomization

Linkage to HIV treatment was assessed as a dichotomous (yes/no) measure of whether participants who tested HIV-positive formally sought treatment. The number/percentage of HIV positive participants who sought treatment within 12 months from randomization is summarized by study arm/group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 12 months from randomization

Linkage to ART initiation was assessed as a dichotomous (yes/no) measure of whether participants who tested HIV positive initiated ART treatment. The number/percentage of HIV positive participants who initiated ART within 12 months from randomization is summarized by study arm/group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 12 months from randomization

Linkage to PrEP was assessed as a dichotomous (yes/no) measure of whether participants who tested HIV negative were on a PrEP regimen. The number/percentage of HIV negative participants who were on a PrEP regimen within 12 months from randomization is summarized by study arm/group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 12 months from randomization

Linkage to counseling was assessed as a dichotomous (yes/no) measure of whether participants received counseling treatment. The number/percentage of participants who received status neutral counseling treatment within 12 months from randomization is summarized by study arm/group.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 18 months from randomization

a composite of linkage to PrEP, counseling, or HIV treatment (yes/no)